Novartis Submits NDA for Capmatinib in China Targeting METex14 Skipping Mutation-Positive NSCLC

On February 25, the CDE website showed that Novartis' new drug application for capmatinib hydrochloride tablets was accepted for the treatment of patients with metastatic non-small cell lung cancer harboring MET exon 14 (METex14) skipping mutations.

Capmatinib is a potent, orally available, selective, ATP-competitive c-Met kinase inhibitor with high selectivity for c-Met. It effectively inhibits c-Met-dependent tumor cell proliferation and migration, induces apoptosis, and exhibits anti-tumor activity. Compared with other c-Met inhibitors, it has the highest inhibitory effect on METex14.

From May 2020 to present, capmatinib has been successively approved for marketing in the United States, Japan, the European Union, Switzerland, Brazil, Singapore, and other countries and regions. It is also prioritized in international lung cancer guidelines as a recommended treatment for METex14 exon skipping mutations in non-small cell lung cancer across all lines of therapy.

In December 2022, Novartis presented the registration (GeoMETry-C) clinical study data of capmatinib for Chinese patients with METex14 skipping mutations in advanced non-small cell lung cancer at the 2022 European Society for Medical Oncology Asia Congress (ESMO ASIA). The results showed that capmatinib was effective in treating Chinese patients with METex14 skipping mutations in advanced non-small cell lung cancer, with overall efficacy and safety data consistent with the global registration clinical study GEOMETRY mono-1.

In the first-line treatment of METex14-mutated advanced non-small cell lung cancer, the objective response rate (ORR) assessed by the independent review committee (BIRC) for capmatinib was 53.3% (95% CI: 26.6, 78.7); the ORR assessed by investigators was 60% (95% CI: 32.3, 83.7), and the disease control rate (DCR) was 86.7% (95% CI: 59.5, 98.3). Among Chinese patients with METex14 mutations and brain metastases, capmatinib also demonstrated a favorable intracranial response rate. The overall intracranial response rate (OIRR) was 50% (95% CI: 6.8, 93.2), with two patients achieving complete response (CR), and the intracranial disease control rate (IDCR) reached 100% (95% CI: 39.8, 100.0).

Lung cancer is the malignant tumor with the highest incidence and mortality rate in China. In 2020, there were 816,000 new cases of lung cancer in China, accounting for 17.9% of all new cancer cases, with 715,000 deaths, making up 23.8% of total cancer-related deaths. METex14 skipping mutations, as a rare driver mutation in lung cancer, occur in approximately 3%-4% of lung adenocarcinomas. Considering the large population base of lung cancer patients in China, rare mutations are not so rare.

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